Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 447-920-2 | CAS number: 897393-42-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.74 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 75 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 218.48 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No long-term repeated dose toxicity study via the inhalation route of administration is available for the test substance. Data available from an oral prenatal developmental study in rabbits (Barnett, 2020) shows a NOAEL of 75 mg/kg bw/day. This NOAEL was selected as a dose descriptor starting point. For the route-to-route extrapolation from oral to inhalation, the dose descriptor starting point = 75 mg/kg bw/day x 1/(0.23 m³/kg bw/d) x 6.7 m³/10 m³ x 1 = 218.48 mg/m³. The oral dose for rabbits was converted to the corresponding air concentration using a standard breathing volume for the rabbit (0.23 m3/kg for 8 hours exposure of workers). For workers, the resulting air concentration needs to be additionally corrected for the difference between basal caloric demand and caloric demand under light activity. This correction factor derives from the inhalative volumes in 8 hours under the respective conditions (6.7 m³ for base level, 10 m³ for light activity). No correction for bioavailability via the inhalation route is made as for both the oral and the inhalatory route, 100% absorption is assumed.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as starting point, no additional assessment factor is required
- AF for differences in duration of exposure:
- 2
- Justification:
- The default assessment factor for difference in duration from a subacute to chronic toxicity would be 6. A deviating assessment factor of 2 is considered for the following reasons: the selected dose descriptor starting point NOAEL of 75 mg/kg bw/day was determined based on maternal toxicity effects in a prenatal development study in rabbits. This maternal toxicity was observed at dose levels lower than observed in other repeated dose toxicity studies. The differences in experimental exposure duration and duration of exposure of the pregnant population could be considered minor. It is generally assumed that pregnant animals are more sensitive than non-pregnant animals. Exposure to the test substance during pregnancy is to be avoided for the worker population.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- included in the route-to-route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- default assessment factor for rats
- AF for intraspecies differences:
- 5
- Justification:
- default assessment factor for worker population
- AF for the quality of the whole database:
- 1
- Justification:
- default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- default assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.25 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 60
- Dose descriptor starting point:
- NOAEL
- Value:
- 75 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 75 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No long-term dermal repeated dose toxicity study is available for the test substance. Data available from an oral prenatal developmental study in rabbits shows a NOAEL of 75 mg/kg bw/day. This NOAEL was selected as dose descriptor starting point. For the route-to-route extrapolation from oral to dermal, on the assumption that dermal absorption will not be higher than oral absorption, no default factor (i.e. factor 1) should be applied as part of the overall assessment factor.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as starting point, no additional assessment factor is required
- AF for differences in duration of exposure:
- 2
- Justification:
- The default assessment factor for difference in duration from a subacute to chronic toxicity would be 6. A deviating assessment factor of 2 is considered for the following reasons: the selected dose descriptor starting point NOAEL of 75 mg/kg bw/day was determined based on maternal toxicity effects in a prenatal development study in rabbits. This maternal toxicity was observed at dose levels lower than observed in other repeated dose toxicity studies. The differences in experimental exposure duration and duration of exposure of the pregnant population could be considered minor. It is generally assumed that pregnant animals are more sensitive than non-pregnant animals. Exposure to the test substance during pregnancy is to be avoided for the worker population.
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- default assessment factor, rabbit to human
- AF for other interspecies differences:
- 2.5
- Justification:
- default assessment factor
- AF for intraspecies differences:
- 5
- Justification:
- default assessment factor for worker population
- AF for the quality of the whole database:
- 1
- Justification:
- default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- default assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - General Population
No consumer use is expected, therefore no hazard assessment for the general population is performed.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
